MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC

Model Number	72400168
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Codes	Incontinence (1928); Urinary Incontinence (4572); Insufficient Information (4580)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, used first date of the aware month.
Event or Problem Description
It was reported that the patient had the artificial urinary sphincter removed due to fluid loss from a cuff defect.A new artificial urinary sphincter consisting of a cuff, pump, and balloon was implanted.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes based on analysis results, the cause that contributed to the reported mechanical issue and fluid leak damage would affect the functionality of the device and would therefore be the most probable cause for the reported urinary incontinence issues.Device history record review (dhr): the device history record review (dhr) confirmed the device met all manufacturing specifications, a risk review confirmed that the event is accounted for in the risk documentation.Label review: there is no objective evidence that the user did not properly handle or use the device according to the ifu, ams 800 male ous, bsc.Additionally, the reported events do not contain an allegation against the labeling.Urinary incontinence (positional/recurrent) is included as a potential adverse event in the product labeling.Device technical analysis: returned product consisted of an ams 800 occlusive cuff.The cuff component was visually inspected, microscopically examined, and tested for leaks.A pinhole tear was identified in the cuff pillow consistent with wear at a corner of a fold in the cuff.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Investigation conclusion: based on this investigation a clear probable cause for the event was established; therefore, the conclusion code of cause traced to component failure has been chosen.
Event or Problem Description
It was reported that the patient had the artificial urinary sphincter removed as the patient was incontinent due to fluid loss from a cuff defect.During the revision surgery, they discovered a super full balloon and a cuff with openings.A new artificial urinary sphincter consisting of a cuff, pump, and balloon was implanted.The surgery went well.
Event or Problem Description
It was reported that the patient had the artificial urinary sphincter removed as the patient was incontinent due to fluid loss from a cuff defect.During the revision surgery, they discovered a super full balloon and a cuff with openings.A new artificial urinary sphincter consisting of a cuff, pump, and balloon was implanted.The surgery went well.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11674913
• Report Number: 2124215-2021-08773
• Device Sequence Number: 3355890
• Product Code: EZY
• UDI-Device Identifier: 00878953000794
• UDI-Public: 00878953000794
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/23/2019
• Device Model Number: 72400168
• Device Catalogue Number: 72400168
• Device Lot Number: 890560003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 04/02/2021; 05/10/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 04/27/2021; 06/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention